Electrosurgical Generator And Accessories

Electrosurgical, Cutting & Coagulation & Accessories

Medrange

The following data is part of a premarket notification filed by Medrange with the FDA for Electrosurgical Generator And Accessories.

Pre-market Notification Details

Device IDK201224
510k NumberK201224
Device Name:Electrosurgical Generator And Accessories
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Medrange 480 Apollo Street, Suite D. Brea,  CA  92821
ContactHelen Xie
CorrespondentHelen Xie
Medrange 480 Apollo Street, Suite D. Brea,  CA  92821
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-06
Decision Date2020-09-18

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